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Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT00646191
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : March 28, 2008
Sponsor:
Information provided by:
Abbott

Brief Summary:
Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Condition or disease Intervention/treatment Phase
Psoriasis Drug: adalimumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter Extension Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study Start Date : March 2003
Actual Primary Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A Drug: adalimumab
40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse
Other Names:
  • ABT-D2E7
  • Humira
Active Comparator: B Drug: adalimumab
40 mg weekly through Week 48 (OL Week 12 - 48)
Other Names:
  • ABT-D2E7
  • Humira
Active Comparator: C Drug: adalimumab
80 mg W0, 40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse
Other Names:
  • ABT-D2E7
  • Humira



Primary Outcome Measures :
  1. Psoriasis Area and Severity Index [ Time Frame: Week 12 ]
  2. Adverse Events [ Time Frame: Throughout Study Participation ]

Secondary Outcome Measures :
  1. Psoriasis Area and Severity Index [ Time Frame: Week 0, 4, 8, 12, 16, 20, 24, 32, 40 and 48 ]
  2. DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D, VAS [ Time Frame: Week 12, 24 and 48 ]
  3. Physician's Global Assessment [ Time Frame: Week 12, 16, 20, 24, 32, 40 and 48 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject completed prior PS study

Exclusion Criteria:

  • Subject has other active skin diseases
  • Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
  • Poorly controlled medical conditions
  • History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
  • History of cancer or lymphoproliferative disease
  • History of active TB or listeriosis, or persistent chronic or active infections
  • Known to have immune deficiency or is immunocompromised
  • Clinically significant abnormal laboratory test results
  • Erythrodermic psoriasis or generalized pustular psoriasis

Responsible Party: Beverly Paperiello / Director, Clinical Program Management, Abbott
ClinicalTrials.gov Identifier: NCT00646191     History of Changes
Other Study ID Numbers: M02-529
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents